FDA Hits Halyard Health With a Class 1 Recall

FDA Hits Halyard Health With a Class 1 Recall

FDA hits Halyard Health with a class 1 recall, the most serious type of recall, when “there is a reasonable probability these products will cause serious adverse health consequences or death”. The decision for this recall is due to the cuff inflation line of certain KimVent Microcuff Endotracheal tubes which may become detached from the tube during use. If the inflation line detaches, the cuff will gradually deflate. This may lead to an air leak between the cuff and the tracheal wall, which in turn may reduce the amount of air that reaches the lungs.

19 cases of device malfunctioning were reported. In most cases, patients were required a reinsertion of endotracheal tubes.

FDA warned the use of this recalled product could cause serious health risks, including delayed patient treatment, breathing difficulties, and death.

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